Subject: Lenvima 1865-A SGM P2023a
Policy:
I. INDICATIONS
The indications below including FDA-approved indications and
compendial uses are considered a covered benefit provided that
all the approval criteria are met and the member has no
exclusions to the prescribed therapy.
A. FDA-Approved Indications
1. Lenvima is indicated for the treatment of patients with
locally recurrent or metastatic, progressive, radioactive
iodine-refractory differentiated thyroid cancer (DTC).
2. Lenvima is indicated in combination with pembrolizumab
for the first line treatment of adult patients with advanced
renal cell carcinoma.
3. Lenvima is indicated in combination with everolimus, for
the treatment of adult patients with advanced renal cell
carcinoma (RCC) following one prior anti-angiogenic
therapy.
4. Lenvima is indicated for the first-line treatment of
patients with unresectable hepatocellular carcinoma
(HCC).
5. Lenvima is indicated in combination with pembrolizumab,
for the treatment of patients with advanced endometrial
carcinoma (EC) that is mismatch repair proficient
(pMMR), as determined by an FDA-approved test, or not
microsatellite instability-high (MSI-H), who have disease
progression following prior systemic therapy in any
setting and are not candidates for curative surgery or
radiation.
B. Compendial Uses
1. Anaplastic, medullary, follicular, oncocytic/Hurthle cell, or
papillary thyroid carcinoma
2. HCC
3. Relapsed RCC
4. Recurrent endometrial carcinoma
5. Thymic carcinoma
6. Cutaneous melanoma
All other indications are considered experimental/investigational
and not medically necessary.
II. DOCUMENTATION
Submission of the following information is necessary to initiate
the prior authorization review: Documentation of laboratory
report confirming mismatch repair (MMR) tumor status, where
applicable.
III. CRITERIA FOR INITIAL APPROVAL
A. Thyroid carcinoma
Authorization of 12 months may be granted for treatment of
thyroid carcinoma when any of the following criteria are met:
1. Member has follicular, oncocytic/Hürthle cell, or papillary
thyroid carcinoma not amenable to radioactive iodine
therapy (RAI).
2. Member has medullary thyroid carcinoma and has
progressed on vandetanib (Caprelsa) or cabozantinib
(Cometriq) OR these therapies are inappropriate
3. Member has stage IVC anaplastic thyroid carcinoma and
requested drug will be used in combination with
pembrolizumab (Keytruda)
B. Renal Cell Carcinoma
Authorization of 12 months may be granted for treatment of
advanced, relapsed or stage IV renal cell carcinoma when
used in any of the following settings.
1. The requested drug will be used in combination with
everolimus (Afinitor) and either of the following is met:
i. The disease histology is predominantly clear cell and
the member has used prior therapy OR
ii. The disease histology is non-clear cell
2. The requested drug will be used in combination with
pembrolizumab (Keytruda).
C. Hepatocellular Carcinoma
Authorization of 12 months may be granted for treatment of
hepatocellular carcinoma as a single agent when any of the
following criteria are met:
1. Member has unresectable disease and is not a transplant
candidate
2. Member has local disease, inoperable by performance
status, comorbidity, or with minimal or uncertain
extrahepatic disease
3. Member has metastatic disease or extensive liver tumor
burden
D. Endometrial Carcinoma
Authorization of 12 months may be granted for treatment of
advanced, metastatic or recurrent endometrial carcinoma
when used in combination with pembrolizumab (Keytruda)
when either of the following are met:
1. The disease is mismatch repair proficient (pMMR)
2. The disease is mismatch repair deficient (dMMR) and has
progressed following prior platinum-based chemotherapy
E. Thymic Carcinoma
Authorization of 12 months may be granted for treatment of
thymic carcinoma when used as a single agent.
F. Cutaneous Melanoma
Authorization of 12 months may be granted for treatment of
metastatic or unresectable cutaneous melanoma that has
progressed following treatment with an anti-PD-1/PD-L1-
based therapy, in combination with pembrolizumab.
IV. CONTINUATION OF THERAPY
Authorization of 12 months may be granted for continued
treatment in members requesting reauthorization for an
indication listed in Section III when there is no evidence of
unacceptable toxicity or disease progression while on the current
regimen.
Place of Service:
Outpatient
The above policy is based on the following references:
- Lenvima [package insert]. Nutley, NJ: Eisai Inc.; November 2022.
- The NCCN Drugs & Biologics Compendium 2024 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed February 1, 2024.
- National Comprehensive Cancer Network (NCCN) Guidelines: Thyroid Carcinoma V1.2024. National Comprehensive Cancer Network, Inc. https://www.nccn.org/professionals/physician_gls/pdf/thyroid.pdf. Accessed February 1, 2024.
- Micromedex (electronic version). Truven Health Analytics. Greenwood Village, Colorado, USA https://www.micromedexsolutions.com/. Accessed August 21, 2023.
Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
March 14, 2024
